January 2024

Yes, a “single biomolecule” means one biomolecule

Patent

by Dennis Crouch

Pacific BioSciences v. Personal Genomics (Fed. Cir. 2024)

PacBio was partially successful in its IPR against Personal Genomics that resulted in cancellation of some claims of US7767441.  Both sides appealed with PacBio wanting all the claims cancelled, and Personal Genomics wanting restoration of its patent rights. The case focuses on preamble claim construction and interpreting the prior art.

Construing the Preamble: The claims were directed to “an apparatus for identifying a single biomolecule, comprising” three different elements. The preamble here has a purposive statement “for identifying a single biomolecule,” and a key question in the case is whether the preamble should be limiting. In the IPR, the patentee wanted a narrow construction – giving effect to the preamble – in order distinguish its invention from prior art apparently not capable of single-molecule identification.

The PTAB found the preamble as limiting and the Federal Circuit affirmed that holding on appeal. This is probably a case where the PTAB’s move to the Phillips v. AWH standard from Broadest-Reasonable-Interpretation during inter partes review.

The general presumption in patent claim construction is that the preamble is not limiting for obviousness purposes. But, the preamble can be given weight when it crosses some threshold of providing important meaning to the claimed invention.  Here, the preamble identified “a single biomolecule” and body of the claim referenced “the biomolecule.”  This antecedent basis for referencing the biomolecule was enough for the PTAB find the preamble limiting, and that construction was not appealed.

What was appealed was the actual construction of “a single biomolecule.”  Petitioner argued that the claims should cover identifying a biomolecule by making copies, examining the resulting ensemble, and inferring the identity of the original molecule. But the court rejected this, finding it inconsistent with the language of the claim as supported by the specification describing problems of such ensemble approaches.  Of interest, the court decided that the ordinary meaning of “identifying” should be applied and thus cited two dictionary definitions.

A final note on this preamble construction is that it could also be given no meaning because it appears simply state the purpose of the device (and thus not really limiting) rather than a structural limitation (that would be limiting).  On appeal, the Federal Circuit noted that this issue was not challenged on appeal, but that there is precedential to support the notion that the phrase “for identifying a single biomolecule” is a limitation on the capability of the machine rather than simply a statement of purpose.

Scope of the Prior Art: One of the key prior art references (Hassibi) described its detection sensitivity “as low as 0.1 attomoles,” which is >60,000 molecules.  Thus, the court was able to affirm that Hassibi does not meet the requirement of identifying a single biomolecule.

The patentee also argued that a second reference (Choumane), did not detect a single molecule.  The patentee’s expert conducted a number of calculations and testified that Choumane’s sensitivity required at least 78 biomolecules — i.e., more than one.  But, the text of Choumane disclosed “detection and observation of individual [biomolecules].”  On appeal, the Federal Circuit recognized that that the expert’s calculations might have merit, but that the Board had substantial evidence to support its conclusion that Choumane disclosed a single molecule detector.

[T]his type of calculation can be proper where based on the express disclosures of a
piece of prior art. In this case, however, the Board, considering the calculation, had sufficient reason, in light of the Choumane statement quoted above, to reject the inference about Choumane that PGI offered the calculation to support.

Id.  Although obviousness is a question of law, it must be supported by various factual findings, including a determination of the scope and content of the prior art.  This means that the Court gives deference to the PTAB — affirming its factual finding so long as there is enough evidence available that a reasonable fact finder could rule as the Board ruled.  See Shoes by Firebug LLC v. Stride Rite Children’s Group, LLC, 962 F.3d 1362, 1369 (Fed. Cir. 2020).

Edward Reines of Weil Gotshal argued for the patentee; Keith Orso of Irell & Manella argued for petitioner. The panel included judges Prost, Taranto, and Hughes, with Judge Taranto authoring the opinion.

A publication “by others” under pre-AIA Section 102

Patent

by Dennis Crouch

The text of pre-AIA Section 102(a) suggests that an inventor’s own prior publication qualifies as invalidating prior art, even if within the 1-year grace period.  Although the statute includes a “by others” caveat, the clause’s grammar suggests that qualification only applies to prior art created by being “known or used” and does not apply to printed publications.  Here is the statute:

A person shall be entitled to a patent unless —(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent.

35 U.S.C. § 102(a)(pre-AIA).  In the statute, “by others” modifies “known or used” but does not appear to modify “patented or described in a printed publication.”  As the Federal Circuit’s precursor explained, a strait reading of the statute “would negate the one year period afforded under § 102(b) during which an inventor is allowed to perfect, develop and apply for a patent on his invention and publish descriptions of it if he wishes.” In re Katz, 687 F.2d 450 (C.C.P.A. 1982).  In Katz, the court recognized the difficulty in the statute, but determined that a non-grammatical reading was the best reading in order to protect grace period rights.  Id.

A case pending before the Federal Circuit focuses on the meaning of “by others” and asks whether a press release by the patent owner quoting one of the inventors qualifies as prior art under 102(a).  Salix Pharmaceuticals et al. v. Norwich Pharmaceuticals, Docket No. 22-2153 (Fed. Cir.).  Oral arguments were held January 8 2024, and a decision is expected later this year.

The case centers on two patents covering methods of using the drug rifaximin to treat irritable bowel syndrome with diarrhea (IBS-D). U.S. 8,309,569 and U.S. 10,765,667.  Both patents have priority dates from early 2008. In finding the claims obvious, the lower court relied largely on a September 2007 press release from the patentee reporting positive Phase II trial results on using a particular dosage of rifaximin to treat IBS-D.  Although the press release does not disclose exact invention eventually claimed, it does disclose aspects of the invention that arguably renders the subsequent claims obvious.   (Although I don’t write about it here, the patentee argues that even if the press release is prior art, it still does not render the claimed invention obvious).

The press release specifically quotes and references Dr. Bill Forbes, who is listed as an inventor on the IBS-D patents. This press release is also discussed in the patent specifications. Salix argues this means the press release reflects the inventor’s own work, not the work of “others,” and thus does not qualify as prior art that can be used against the patents.

At oral argument, the attorney for Salix, William Peterson (MorganLewis), focused on how Norwich as the challenger failed to carry its burden of proving by clear and convincing evidence that the press release was prior art – i.e., that it reflected work done by “others” not inventors. He reiterated how the press release quotes the inventor and patents describe the underlying study, clearly tying it to the inventors. In his view, this means it cannot be Section 102(a) prior art used to invalidate the patents as obvious.

But the judges pushed back with probing questions about inventor Forbes being quoted and whether that alone makes the press release not prior art. They suggested that the face of the press release gives no indication or reason to assume it is solely reflects the inventor’s work.  The suggestion here is that a publication by someone other than an inventor will be assumed to be “by others” — shifting the burden to the patentee to at least present a prima facia case that the release was not by others. Thus, a central issue here is who bears the burden with respect to showing whether the release reflects “others” vs the inventors.

This issue was solved in the AIA with Section 102 no longer using the words “by others.” Still, we’ll be litigating lots of pre-AIA cases the next decade. A similar issue does arise under AIA 102(b) in terms of who has the burden of proving whether a disclosure was derived from the inventor.

William Peterson (MorganLewis) argued on behalf of the patentee and Chad Landmon (Axinn) on behalf of Norwich.  

Supreme Court Denies Certiorari in Three Patent Cases

Patent

The Supreme Court announced on Monday, January 8, 2024, it has denied certiorari petitions in three patent cases that we have been watching. This leaves the Federal Circuit rulings intact.  It also means that the court is unlikely to hear a patent case this term.

The first case is Intel Corp. v. Vidal, which challenged the Patent Trial and Appeal Board’s “Fintiv rule.” This policy allows the PTAB to use the director’s delegated discretion to deny inter partes review petitions if, for instance, parallel litigation in district court is progressing quickly. Intel argued the rule is arbitrary, overly restrictive, and skirted proper rulemaking procedures. But the Federal Circuit said decisions on whether to institute reviews cannot be appealed. Although the Supreme Court has declined to take-up the issue, Dir. Vidal has already narrowed the approach taken under Dir. Iancu and will potentially go further.

The second case, Realtime Data v. Fortinet, involved eligible subject matter under 35 U.S.C. 101. Realtime alleged the Federal Circuit had expanded eligibility exceptions too broadly and asked SCOTUS to reinforce that most inventions should qualify as patentable. However, the Court turned down Realtime’s appeal.

Finally, Traxcell Techs v. AT&T raised a narrow question on whether attorney’s fees can be awarded for “baseless” litigation actions taken after a magistrate judge’s recommendation but before final confirmation by the district judge. Here too though, the Supreme Court denied cert, leaving the Federal Circuit’s answer that “yes, fees were appropriate.” (paraphrasing).

With these three denials on widely-varying patent issues, the Court seems inclined to let CAFC precedent control in these areas for now.

There are still two pending petitions, with VirnetX having a much greater shot than Tehrani.

  • VirnetX Inc. v. Mangrove Partners Master Fund, Ltd., No. 23-315. The VirnetX petition focuses on the Federal Circuit’s interpretation of the inter partes review (“IPR”) joinder provisions and the requirements of the Federal Vacancies Reform Act (“FVRA”).  Both Cato and BIO filed briefs in support of the petition.
  • Tehrani v. Hamilton Technologies LLC, No. 23-575.  The petition raises issues of obviousness, expert qualifications, claim interpretation, etc.  I wrote previously that although the issues are super interesting, “the petition largely re-argues the evidence — typically a losing approach at the Supreme Court” petition stage.

Federal Funded Innovation and March-In Rights

Patent

by Dennis Crouch

The Biden Administration is seeking comment on its proposed framework for how how agencies should evaluate exercising “march-in rights” over federally funded inventions. For those familiar with march-in rights, this guidance has been a long time coming. While these powers have technically existed for years under the Bayh-Dole Act, the lack of clear procedures around their use has rendered them largely theoretical. This proposal could change that.

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Sharon Israel, PTO New Chief Policy Officer

Patent

Congratulations to Sharon Israel on her new leadership role at the USPTO.  I was happy to learn that Director Vidal has appointed Sharon Israel as its new Chief Policy Officer and Director for International Affairs. Ms. Israel has been a leader of the patent bar for many yeas and will bring tremendous expertise to this important role overseeing the USPTO’s policy and international programs.  For the past few years, she has been a partner at Shook Hardy focusing on patent litigation — primarily on the defense side. (more…)

Plagiarism Police come for Winston & Strawn

Patent

Hsuanyeh Law Group v. Winston & Strawn, 23-cv-11193 (S.D.N.Y. 2024)

A recent copyright infringement lawsuit filed by small Boston intellectual property boutique Hsuanyeh Law Group PC (HLG) against international giant Winston & Strawn LLP focuses a dividing line that can highlight when copying the work of another firm is permissible.  I believe that Winston & Strawn will eventually prevail based upon a fair use defense, but it is still an embarrassing situation for the firm and attorneys involved.  I hope that they did not overbill the client.  The role of attribution is also receiving increasing focus as attorneys begin to rely more heavily on AI outputs for their legal documents.

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Federal Circuit Affirms Invalidity of Genus Claims to Stevia Production Method Lacking Written Description and Narrower Claims as Combining Natural Phenomena with an Abstract Idea

Patent

by Dennis Crouch

In PureCircle USA Inc. v. SweeGen, Inc., No. 22-1946 (Fed. Cir. Jan. 2, 2024) (non-precedential) [PureCircle Decision], the Federal Circuit affirmed a district court summary judgment siding against the patentee, PureCircle.  The court concluded that the stevia production method claims were all invalid, either for: (1) lack of written description for the genus claim or (2) lack of eligibility because the claims are directed to a natural phenomenon combined with an abstract idea.  Judge Dyk authored the opinion of the court that was joined by Judges Schall and Stark affirming the ruling of C.D.Cal Judge James Selna.

The written description portion of the opinion parallels the Supreme Court’s 2023 Amgen decision that focused on the sibling doctrine of enablement. Although non-precedential, the eligibility portion appears important because of the way it combines prohibited eligibility categories and rules that method claims requiring a particular purity level are themselves an abstract idea absent requirement of specific steps on how that purity level is achieved.

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The First Precedential Patent Decision of 2024: Dexcom v. Abbott Diabetes Care

Patent

by Dennis Crouch

The U.S. Court of Appeals for the Federal Circuit has begun 2024 [2023] with its first precedential patent decision in DexCom, Inc. v. Abbott Diabetes Care, Inc., 2023-1795 (Fed. Cir. January 3, 2024).  In an opinion by Judge Stoll, the court affirmed a district court decision denying DexCom’s motion for a preliminary injunction. The patentee had requested an order barring Abbott from pursuing its IPR challenges – based upon a forum selection clause that was part of a prior settlement between the parties. Judges Dyk and Hughes were also on the panel.

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Patent Law Exam 2023: Are you Smarter than a Law Student?

Patent

by Dennis Crouch

The following is my patent law exam from this past semester. As in years past, the exam was worth less than half of the final grade because the students did other substantial work during the semester, including a major moot court competition.   Students were permitted access to their book/notes/internet, but were barred communications with another human during the exam.

This year’s exam is very loosely based upon an interesting patent that I found associated with the Tow Whee product created by Eric Landis.  See US11167164, US11731470, and US11724148.  But, the events described are entirely my creation.

= = =

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Coffee and Claim Construction: The Plain and Ordinary Meaning of “Barcode”

Patent

Guest Post by Jordan Duenckel. Jordan is a third-year law student at the University of Missouri and a registered patent agent. He has an extensive background in chemistry and food science.  

A recent Federal Circuit opinion, K-Fee v. Nespresso, 2022-2042, — F.4th — (Fed. Cir. Dec. 26, 2023), arises from an infringement suit filed by K-fee System GmbH against Nespresso USA, Inc. in the Central District of California and revives a coffee controversy. K-fee owns three related patents (the ‘176, ‘177, and ‘531 patents) concerning coffee capsules that display information via a “barcode” which is read by the coffee machine to control the beverage production process. The key dispute is over the meaning of “barcode” and whether there was any prosecution disclaimer.

The technology underlying the dispute is individual coffee pods that have a barcode located on the outer rim of the pod that the coffee machine can read to self-adjust temperature, water amount, and other characteristics to brew different types of coffee all without user input creating a “one touch” gourmet coffee maker. Depending on the pod, our Nespresso machine can make expresso, a double expresso for the wife, or just a cup of black coffee for me. 

K-fee owns U.S. Patent No. 10,858,176 and claim one reads in part:  

1. A method of making a coffee beverage comprising: 

providing an apparatus including a barcode reader; 

inserting a first portion capsule into the apparatus, the first portion capsule including . . . an opposing bottom side with a first barcode located on the bottom side, . . . ; 

reading the first barcode with the barcode reader; 

controlling a production process of a first coffee beverage based upon the reading of the first barcode; 

The initial issue is the plain and ordinary definition of a barcode as both parties agree that the plain and ordinary definition is appropriate but disagree about what that meaning is. The district court issued a claim construction order construing “barcode,” relying on statements K-fee made distinguishing certain prior art (Jarisch) during prosecution of a related European patent before the European Patent Office (EPO). Based on K-fee’s statements that Jarisch discloses a “bit code” rather than a barcode, the district court construed barcode to exclude the type of bit codes in Jarisch. The district court granted summary judgment of non-infringement to Nespresso, finding that its accused coffee capsules use a code identical to Jarisch’s bit codes.  

The Federal Circuit reviewed appeal of the claim construction de novo because the claim construction relied only on intrinsic evidence. The claims and specification did not define “barcode,” so the court looked to the prosecution history, specifically K-fee’s statements distinguishing the Jarisch reference before the European Patent Office. Specifically examined were what the statements would indicate to a person having ordinary skill in the art about the meaning of “barcode.” K-fee presented evidence consisting of quotes from technical publications describing “barcode” as a code with bars of varying widths. K-fee also explicitly stated “the [skilled artisan] at all times defines the term ‘barcode’ as a line code constructed of bars having variable widths.” Additional confirmation is in K-fee’s statement that standard UPC retail barcodes fall within the scope of its claims. Since K-fee did not describe anything about how retail barcodes encode data, this further indicates K-fee was focused only on the visual appearance of varying width bars when referring to “barcodes.” 

Judge Taranto concludes a skilled artisan would not understand K-fee’s statements as excluding all bit codes from the scope of “barcode.” He specifically points to K-fee explicitly stating that retail barcodes like UPC codes are barcodes, even though they contain binary code elements. Citing Phillips v. AWH Corp.,415 F.3d 1303, 1312-17 (Fed. Cir. 2005), Judge Taranto found that the ordinary meaning of “barcode” to a relevant artisan focuses on visual appearance – i.e. a linear sequence of visually non-uniform width bars and concluded that the district court erred in narrowing the ordinary meaning of “barcode” based on K-fee’s statements to the EPO.  

I am sympathetic to Nespresso’s concern that the focus on visual appearance as to ordinary meaning misses some of the nuance about what the barcodes actually represent and that a relevant artisan would consider their functional purpose. As construed by Judge Taranto, “varying-width visual appearance of the bars” is an extraordinarily broad claim construction that seems to expand the claim scope significantly compared to the more narrow district court construction.    

The corollary issue is whether K-fee’s statements to the EPO are disclaimer of claim scope. Nespresso alleges that K-fee’s statements to the EPO constitute surrender of claim scope that would include their Vertuo coffee pod product. The court notes disclaimer requires “clear and unmistakable” statements, unequivocally disavowing claim scope. Looking at K-fee’s EPO submissions, statements about bit codes being excluded from barcodes were ambiguous rather than clear. For example, K-fee said a barcode “can be, but is not necessarily, a bit code.” This directly contradicts disclaimer of all bit codes. 

Judge Taranto concludes that the prosecution history as a whole does not show K-fee clearly disclaimed any portion of the ordinary meaning of “barcode.” The only thing K-fee clearly distinguished was the Jarisch reference itself, which does not expressly disclose varying width bars. Multiple instances indicate some possible indicia that K-fee disclaimed some scope however, it was not “clear and unmistakeable” as required to find disclaimer.  Therefore, reversing the district court’s construction of “barcode” also necessitated reversing the summary judgment of non-infringement that was based entirely on the erroneous claim construction.